New regulations in the Year 2023 for different regulatory bodies around the world

Drug regulatory body in any country or market is responsible for maintaining the safety, efficacy, and quality of drugs manufactured, sold, and marketed in their relevant area by performing different activities. One of them is updating their existing regulations and defining new ones.

The regulatory bodies continuously update their regulations due to different factors such as new research, feedback from industry experts, and market complaints. These regulations become part of their law, and the member pharma manufacturers must comply.

This article will explore new regulations in countries like the United States, Europe, Japan, and Australia.

United States FDA

United States FDA is responsible for maintaining the drug regulations in the United States. Some new regulations by the FDA are briefed below

Submitting patient reported outcome data in Cancer clinical trials

It guides meeting patient-reported outcome data collected in Cancer clinical trials related to medical products for market application.

Remote interactive evaluation of drug manufacturing and bio research monitoring facilities

This guidance provides details about conducting remote voluntary evaluations for drug manufacturing packing processing compounding or holds under FDA bioresearch monitoring program

Communication from firms to health care providers regarding scientific information on unapproved use of approved / cleared medical products questions and answers

This guidance will provide MDS perspective regarding questions related to certain communications by pharma manufacturers to healthcare providers on unapproved uses of approved cleared medical products

Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol;

This guidance is intended to alert Pharmaceutical manufacturers specializing in drug compounding with ethanol (ethyl alcohol or ethanol or isopropyl alcohol) about methanol contamination.

Diabetic Foot Infections: Developing Drugs for Treatments

This guidance is intended to help sponsors in the clinical development of drugs to treat diabetic foot infections

Stimulant Use Disorders: Developing Drugs for Treatment;

The purpose of this guidance is to assist sponsors of clinical development in the treatment of stimulant use disorders.

Stimulant Use Disorders: Developing Drugs for Treatment;

This guidance assists in labeling dose bands which is based on the previously approved drug product (based on weight or body surface area)

Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products

This is the guidance related to the final meeting between the FDA and the applicants ( or sponsors) when developing a new drug product regulated by CDER and CBER. However, this guidance does not cover abbreviated new drug applications, applications for biosimilar biological products, or medical devices.

Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies

This guidance provides recommendations for clinical trial sponsors in cases where clinical trials can be disrupted due to emergencies or disasters ( such as hurricanes, earthquakes, military conflicts, infectious diseases, or bioterrorist attacks)

Annual Status Report Information and Other Submissions for Post marketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989;

This guidance intends to facilitate drug and biological submissions with complete and accurate information about post market requirements and commitments.

Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products

This guidance intends to provide recommendations to institutional review boards - IRB and clinical investigators to consider specific key factors and procedures when reviewing individual patient-expanded access submissions.

Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product-

This guidance is the formal indication that the FDA intends to extend the enforcement of guidance "Wholesale distributor verification requirement when investigating a suspect or illegitimate product" from 27th November 2023 to 27th November,2024.

Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products

This guidance is added to the FD&C Act under the 21st Century Cures Act. In this guidance, the FDA intends to accelerate the use of real-world evidence in regulatory decision-making.

European Medicines Agency

The European Medicine Agency EMA is the regulatory body responsible for making and enforcing regulations for pharma manufacturers who intend to market and sell their products in European countries. Let's look at some regulations made by EMA in the year 2023

VICH GL60 Good manufacturing practice for active ingredients used in veterinary medicinal products

In this guideline, the EMA provides guidelines about Good Manufacturing Practices for manufacturing Active Pharmaceutical Ingredients - API used in veterinary products. Specifically, it provides guidelines about ensuring quality and purity. This guideline applies to the API manufactured by chemical synthesis, cell culture/fermentation, extraction, recovery from natural resources, or a combination of these methods.

Safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU)

This guide elaborates on the safety and residue data requirements for applications about non-immunological veterinary medicinal products planned for limited markets and not eligible under Article 23 of Regulation (EU) 2019/6

Quality data requirements for applications for biological veterinary medicinal products intended for limited markets

This guideline is about determining the acceptable data requirements that demonstrate the quality of biological veterinary medicinal products.

The use of Artificial Intelligence (AI) in the medicinal product lifecycle

The EMA seeks feedback from all the stakeholders in outlining the view of EMA in using Artificial Intelligence - AI in the medical product lifecycle for both the veterinary and humans. In this regard, the EMA plans to organize a workshop in November 2023

Establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorization

This document contains the view of the EMA (Committee for Medicinal Products for Human Use) on single-arm trials that become the basis for proving efficacy in marketing authorization applications.

Development of a guideline on the quality aspects of mRNA vaccine

This is the draft of the guidance that EMA plans to prepare and enforce regarding the quality principles of mRNA vaccines. It plans to address specific areas of mRNA vaccine such as manufacturing, characterization, specification, and analytical control.

Pharmaceuticals and Medical Devices Agency - Japan

The Pharmaceuticals and Medical Devices Agency - PDMA is the regulatory body for the drugs manufactured and marketed in Japan. Let's see some regulations made by PDMA in the Year 2023

Procedure for Remote Inspection as a Part of Compliance Inspection on Drugs and Regenerative Medical Products

This is the PDMA guideline on the compliance inspection performed remotely through a cloud and video conferencing systems. With the issuance of this notification, the former information on remote inspection is abolished.

Points to Consider for Informed Consent Using Electromagnetic Means in Clinical Trials and Post-marketing Clinical Trials

This notification/guideline is about the consent of the individual involved in the clinical and post-market clinical trials of drugs, medical devices, and regenerative medicinal products. It provides points to consider when obtaining consent using displayed documents, electromagnetic means, video calls, etc.

Therapeutic Goods Administration - Australia

Therapeutic Goods Administration is Australia's regulatory body. Let's look at some regulations for 2023.

Export of human substances guidance

This guide determines whether any individual must obtain an export permit to export human-origin goods (that are regulated as biologicals or medicines)

Personalized medical devices (including 3D-printed devices)

This guidance is about manufacturing medical devices that are manufactured and designed according to the requirements of individuals. It provides regulatory guidelines related to these devices.

GMP clearance application and submission user guide

This guidance document intends to provide guidelines for applying for Good Manufacturing Practice - GMP using TGA Business Services.

Boundary and combination products

This guidance informs sponsors and manufacturers of boundary and combination products about all the requirements involved in the entire manufacturing life cycle.

Special Access Scheme and Authorised Prescriber Pathway

This guidance provides Australian-registered practitioners access to unapproved drug products for individual patients, depending on the nature of the case. (An un-approved drug is when it is not registered in the Australian Register of Therapeutic Goods - ATRG, but is allowed to be imported, exported, or supplied in Australia on an urgent / need basis)

Advertising guidance for Intravenous (IV) products

This guidance is about advertising Intravenous products in Australia that involve inserting a needle in a vein to deliver the therapeutic product into the body. These can also be called drips, infusions, cannulas, fluids, etc.

Hepatitis B and C viruses IVD self-tests

Self-tests, also called home use, are tests performed to detect serious diseases, but they are prohibited in Australia w.e.f. 10th July, 2010.

On 4th September 2010, the Excluded Purposes Specifications were made by consulting relevant stakeholders, and for this purpose, sponsors for specified self-tests, including HBV and HCV, were allowed.

These guidelines provide a detailed description of regulating self-test devices for HBV and HCV.

Clinical evidence guidelines for medical devices

This guideline is intended for the clinical evidence requirement for medical devices, for both in vitro and diagnostics devices. This is a common reference point for regulators and industry manufacturers to collect relevant data, compile it, and present it per regulatory requirements.

Sunscreen regulation in Australia

This guideline is about sunscreen regulation, and according to this guideline, sunscreens that have a therapeutic effect must follow regulatory requirements to be allowed in Australia. Additionally, therapeutic sunscreen must be listed in the Australian Register of Therapeutic Goods before being supplied in the Australian market.

However, sunscreens that do not have therapeutic effects are not required to follow the regulatory regulations of Australia.